MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RLT281416
Medical Device Problem Codes	Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted, however, the delivery catheter will be provided for analysis.Pre-implant imaging evaluation was sent to gore imaging for analysis.The investigation is in process.Further information will be provided.E2402 was used to cover that the procedure was completed with no harm to the patient.F26 was used to explain that the olive tip was successfully removed with no harm to the patient.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
On (b)(6) 2024, the patient underwent endovascular procedure using gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The gore® dryseal flex introducer sheath (dsf1833/ 27266549) was used for access.Reportedly, the procedure was progressing as planned.After the full deployment of (b)(6), when the physician pulled the catheter out of the sheath, the olive tip was missing.Reportedly, the olive plus approx.3cm of the clear inner lumen was in distal end of the sheath near the valve.The olive tip was successfully removed with no harm to the patient.According to the physician, a tightness in the sheath at the valve caused the olive separation.Also, the physician felt a little difficulty at the valve on insertion but not excessive.The case was completed with patient stable condition.
Event or Problem Description
The physician felt a little difficulty at the valve on insertion but not excessive.It didn¿t appear that any unusual force was used on withdrawal.
Additional Manufacturer Narrative
B5: description summary was updated.H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.B6: imaging evaluation.C20: this code was used to cover that imaging was unable to provide an evaluation in relationship to this event.E2402 was used to cover that the procedure was completed with no harm to the patient.F26 was used to explain that the olive tip was successfully removed with no harm to the patient.B01: the device remains implanted, however, the delivery catheter was provided for the engineering analysis.C24: the delivery catheter was provided to gore for engineering evaluation.The device evaluation showed the following: visual inspection of the returned components confirmed that the leading end of the catheter with the attached leading olive had separated from the rest of the delivery catheter and was not returned for evaluation.The returned portion of the delivery catheter appeared to be intact with no signs of fracture or breakage.The mid olive and shrink tube appeared to be intact with no signs of fracture or breakage.Additionally, the blue polyimide was not visible through the mid olive.Based on the findings of this evaluation, the physician¿s observation that ¿when the physician pulled the catheter out of the sheath, the olive tip was missing¿ could be confirmed.Based on the findings of this evaluation, the physician¿s observation that ¿a tightness in the sheath at the valve caused the olive separation¿ could not be confirmed with the available information.The likely cause for the separation of the leading end of the catheter from the delivery catheter could not be determined with the available information.This type of occurrence will continue to be monitored.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu) warning: do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage or premature deployment have occurred and may result in potential patient harms.Do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter breakage or separation resulting in potential patient harms.If catheter separation occurs, use best medical judgment to determine the appropriate course of action for the patient.Effective removal of the catheter component has been reported through both surgical (e.G.Cut down) and endovascular techniques (e.G.Snaring, sheath removal).
Additional Manufacturer Narrative
H6: code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted, however, the delivery catheter will be provided for the engineering analysis.B6: imaging evaluation.C20: this code was used to cover that imaging was unable to provide an evaluation in relationship to this event.E2402 was used to cover that the procedure was completed with no harm to the patient.F26 was used to explain that the olive tip was successfully removed with no harm to the patient.Further information will be provided.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18577117
• Report Number: 3007284313-2024-03018
• Device Sequence Number: 9080315
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2026
• Device Catalogue Number: RLT281416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 01/31/2024; 03/15/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/06/2024; 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male